- AT-01 shows increased LV uptake and LV amyloid activity in all cardiac ATTR and AL subjects, but in none of the controls (100% accuracy)
- AT-01 demonstrates significantly higher left ventricular uptake in ATTR-CMP participants than florbetapir
SAN FRANCISCO, Sept. 12, 2022 (GLOBE NEWSWIRE) -- Attralus, Inc., a clinical stage biopharmaceutical company developing transformative medicines to improve the lives of patients with systemic amyloidosis, today announced multiple data presentations for AT-01 (iodine (I-124) evuzamitide), the company’s pan-amyloid binding peptide in development as an amyloid-specific imaging agent for the diagnosis and management of all types of systemic amyloidosis. These data were included in poster presentations at the 18th International Symposium on Amyloidosis (ISA) taking place September 4-8, 2022, in Heidelberg, Germany as well as the American Society of Nuclear Cardiology (ASNC) taking place September 8-11, 2022, in Orlando, Florida.
"There is a significant unmet need for better diagnostic methods for systemic amyloidosis patients, and the development of an amyloid-specific imaging agent is profoundly important," said Sharmila Dorbala, MD, MPH, MASNC, Principal Investigator of this study, and Director of Nuclear Cardiology, Brigham and Women’s Hospital. "In this pilot study, AT-01 demonstrated itself as a valuable tool for the quantification of cardiac amyloid burden in both ATTR and AL cardiomyopathy.”
Presentations at ISA and ASNC included data comparing the quantification of left ventricular (LV) cardiac amyloid using AT-01 and 18F-florbetapir PET imaging in both transthyretin wild-type (ATTRwt) and amyloid light chain (AL) amyloidosis with cardiomyopathy (CMP). The study concluded that AT-01 demonstrated uptake in all patients and compared to 18F-florbetapir, AT-01 showed significantly higher left ventricular uptake, without significant difference in amyloid activity in ATTR cardiomyopathy patients.
"Today the diagnosis of amyloidosis is a long, complex process, and many patients with systemic amyloidosis remain undiagnosed," said Gregory Bell, MD, Chief Medical Officer at Attralus. "AT-01 has the potential to be the first non-invasive, pan-amyloid, imaging agent designed to detect all types of systemic amyloidosis across key organs.”
Results Summary
- Study results included 28 participants to date: 9 ATTRwt-CMP (32%), 7 AL-CMP (25%), and 12 controls (43%), with median age 70 years (IQR 64 – 76), and 22 males (79%).
- The median AT-01 and 18F-florbetapir doses were 35.7 MBq (IQR 32.8–39.7) and 273.5 MBq (255.7–315.6), respectively.
- AT-01 showed increased LV uptake and LV amyloid activity in all ATTRwt-CMP and AL-CMP subjects, but in none of the controls (100% accuracy in this pilot study).
- When comparing ATTRwt-CMP to AL-CMP, AT-01 LV mean uptake and LV amyloid activity were similar.
- When comparing AT-01 to 18F-florbetapir, AT-01 showed significantly higher LV mean uptake in ATTRwt-CMP, but similar LV amyloid activity.
- AT-01 uptake was moderately correlated with standard measures of wall thickness and LV mass.
- The novel radiotracer AT-01 was found to detect the presence of cardiac ATTRwt and AL amyloid deposition and appears to quantify amyloid burden appropriately in ATTRwt and AL cardiomyopathy.
ISA Poster Presentation Details
- Poster P187: Quantification of left ventricular amyloid using 124I-p5+14 (AT-01) and 18F-florbetapir positron emission tomography in AL and ATTR amyloidosis
- Presented by: Olivier Clerc, M.D., M.P.H., Research Fellow Amyloidosis Program, Brigham and Women's Hospital
- Session: Poster Presentation: Basic Science and Imaging
- Date/Time: September 6, 2022, 12:05 p.m. – 1:15 p.m. CEST
ASNC Poster Presentation Details
- Poster 203-06: Quantification of Left Ventricular Amyloid in AL and ATTR Amyloid Cardiomyopathy: A Pilot 124I-p5+14 (AT-01) PET/CT and Echocardiography Study
- Presented by: Olivier Clerc, M.D., M.P.H., Research Fellow Amyloidosis Program, Brigham and Women's Hospital
- Session: 203 - Outcomes Research Poster Abstracts
- Date/Time: September 9, 2022, 9:30 a.m. – 10:30 a.m. EDT
Attralus is currently seeking a partner to develop and commercialize AT-01.
For additional information, please visit the ISA 2022 website and the ASNC 2022 website.
About AT-01 (iodine (I-124) evuzamitide) Pan-Amyloid Diagnostic
AT-01 (iodine (I-124) evuzamitide) utilizes the company’s pan-amyloid binding peptide as an amyloid-specific imaging agent to image all types of systemic amyloidosis by PET/CT imaging. In initial clinical trials, AT-01 has been shown to detect multiple types of amyloid deposits, including AL and ATTR, in major organs such as the heart, kidney, liver and spleen. Attralus obtained exclusive rights to commercialize AT-01 under a commercial license agreement with the University of Tennessee Research Foundation. The same pan-amyloid removal (PAR) peptide technology is utilized in AT-02 and AT-04, two of the company’s therapeutic candidates.
About Systemic Amyloidosis
Systemic amyloidosis encompasses a diverse group of rare diseases that occur due to accumulation of toxic amyloid deposits in tissues and organs, a consequence of aberrant protein misfolding events. These diseases are progressive, debilitating and often fatal. Systemic amyloidosis is significantly underdiagnosed due to low awareness, lack of specific symptoms, and no current disease-specific diagnostics. The two most common forms of systemic amyloidosis are immunoglobulin light-chain-associated (AL) amyloidosis and transthyretin-associated amyloidosis (ATTR). There is a significant unmet need for new therapies and diagnostics in systemic amyloidosis.
About Attralus
Attralus is a clinical stage biopharmaceutical company focused on creating transformative medicines to improve the lives of patients with systemic amyloidosis. The company’s proprietary pan-amyloid removal (PAR) therapeutics are designed to directly bind to and remove toxic amyloid in organs and tissues. By targeting the universal disease-causing pathology in systemic amyloidosis diseases, PAR therapeutics have the potential to treat and reverse disease in patients with all types and stages of systemic amyloidosis. Attralus was founded by scientific experts in the field of amyloidosis and the company is headquartered in San Francisco.
Forward-Looking Statements
This press release contains forward-looking statements, including statements related to the efficacy, continued development, and potential of AT-01. Words such as “developing,” “first,” “potential,” "novel," “shown” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Attralus' current expectations. Forward-looking statements involve risks and uncertainties. Attralus' actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties. Attralus expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Attralus' expectations with regard thereto or any change in events, conditions, or circumstances on which any such statements are based.
Contact:
Luke Heagle
Real Chemistry
(910) 619-5764
lheagle@realchemistry.com
